Kallyope has removed one of its weight loss candidates from its pipeline and shifted its focus away from metabolic diseases, putting more emphasis on neurological disorders.
These changes were noticed on the company’s website this week, following the release of results from a Phase II obesity study on ClinicalTrials.gov. The same day, a Phase IIb trial for Kallyope’s migraine treatment, elismetrep (K-304), was also posted.
The modest outcome of the obesity study may explain the lack of attention. While Kallyope’s combination of two oral “nutrient receptor agonists,” K-757 and K-833, showed a more tolerable gastrointestinal (GI) profile compared to other oral treatments, the weight loss results fell short of those achieved by leading competitors.
In 2022, Kallyope raised $236 million in a Series D funding round, based on its metabolic and GI programs. The company tested K-757, alone and combined with K-833, against a placebo in 155 participants with obesity but without diabetes. These compounds were designed to stimulate several appetite-suppressing hormones like GLP-1, PYY, and CCK. After 13 weeks, K-757 resulted in a 1.57% weight reduction, while the combination of K-757 and K-833 saw a 2.94% reduction. The placebo group had a 0.15% weight loss.
However, 14 out of 52 patients in the combination group discontinued treatment due to adverse events. The overall adverse event rate in the cohort was 80.8%, with common side effects including nausea (51.9%), constipation (36.5%), vomiting (23.1%), dyspepsia (19.2%), and diarrhea (11.5%).
K-833 is no longer listed in Kallyope’s pipeline, leaving K-757 as the only disclosed metabolic candidate. The company now lists three undisclosed assets in the discovery stage for metabolic diseases, while its website highlights three neurology programs.
In comparison, Kallyope’s weight loss results appear far behind its competitors. Novo Nordisk’s oral obesity drug achieved a 13.1% weight loss after 12 weeks, a far higher rate than Kallyope’s. Additionally, Roche’s CT-996 showed a 6.1% weight loss in just four weeks in a Phase I study, and Ascletis reported a 6.2% reduction in weight at week four with its oral GLP-1 agonist ASC30.
Eli Lilly’s oral GLP-1 drug, orforglipron, is set to release Phase III data next quarter, with earlier reports showing up to 12.6% weight loss after 26 weeks. This readout is one of the most highly anticipated of the year.
